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A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00292461
First Posted: February 16, 2006
Last Update Posted: May 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
  Purpose
The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.

Condition Intervention Phase
Epilepsy Drug: Zonisamide Drug: Lamotrigine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline [ Time Frame: Baseline and 16 weeks ]
    Percentage Change of Frequency = (T-B)/B*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)* 4 B= The monthly seizure frequence with one month prior to enrollment


Secondary Outcome Measures:
  • Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period [ Time Frame: Baseline and 16 weeks ]
  • Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period [ Time Frame: Baseline and 16 weeks ]
  • Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline. [ Time Frame: Baseline and 16 weeks ]

Enrollment: 64
Study Start Date: March 2006
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: zonisamide
tablet
Drug: Zonisamide
Tablet once or twice daily orally for 16 weeks
Active Comparator: lamotrigine
tablet
Drug: Lamotrigine
Tablet once daily orally for 16 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subjects must sign and date the informed consent form
  • Clinical diagnosis as refractory epilepsy

Exclusion criteria:

  • Progressive neurologic disease
  • Serious psychiatric disease
  • Hemolytic anemia
  • G6PD (glucose-6-phosphate dehydrogenase) deficiency
  • Acute intermittent porphyrias
  • Subjects who have received study drugs (Zonisamide, Lamotrigine) in the past
  • Drug or alcohol addiction
  • Renal impairment (serum creatinine ≧ 1.5 mg/dl), or hepatic abnormality (ALT or AST > 2x ULN)
  • Stevens-Johnson syndrome
  • Progressive exfoliative dermatitis
  • Pregnant, lactating or of childbearing potential female
  • Regularly taking oral contraceptives
  • Hypersensitivity to study drugs
  • Severe cardiac disease (New York Heart Association Functional Class III and IV)
  • History of malignancy within 5 years

    • Taking valproic acid within 7 days prior to screening
    • Subjects with simple partial seizures without motor component
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292461


Locations
China, Taiwan
Changhua Christian Hospital
Changhua, Taiwan, China
Chang-Gung Memorial Hospital (CGMH)
Kaohsiung, Taiwan, China
Chang-Gung Memorial Hospital (CGMH)
Linkou, Taiwan, China
China Medical University Hospital (CMUH)
Taichun, Taiwan, China
National Cheng Kung University Hospital
Tainan, Taiwan, China
Chang-Gung Memorial Hospital (CGMH)
Taipei, Taiwan, China
Taipei Tzu Chi General Hospital
Taipei, Taiwan, China
Taipei Veterans General Hospital
Taipei, Taiwan, China
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Ya-Hui Cheng Eisai Taiwan
  More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00292461     History of Changes
Other Study ID Numbers: E2090-AS886-202
First Submitted: February 14, 2006
First Posted: February 16, 2006
Results First Submitted: September 27, 2010
Results First Posted: August 15, 2011
Last Update Posted: May 20, 2013
Last Verified: August 2009

Keywords provided by Eisai Inc.:
Epilepsy
seizures

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lamotrigine
Zonisamide
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Antioxidants
Protective Agents